Director of EU Compliance
1 day ago
We are recruiting for a Director EU Regulatory Strategy to work on an initial 6-month basis fully remote in the UK.
The successful candidate will lead cross-functional efforts to ensure timely submission of key regulatory documents and maintain currency of EU regulatory requirements and approvals.
Responsibilities:
- Define European regulatory strategy and plan to maximize regulatory success
- Provide strategic and operational input to program teams to achieve program objectives
- Lead MAA review, including response to List of Issues and EU-SmPC negotiations
- Develop regulatory roadmap to inform and guide agency engagement strategy
Requirements:
- Education in life sciences required
- Proven experience in biopharmaceutical industry with deep understanding of EU regulatory requirements
- Demonstrated experience of leading successful engagement with EMA
Salary Range: £80,000 - £100,000 per annum depending on experience
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EU Compliance Expert
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Regulatory Affairs Expert
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